Method of digitally constructing a prosthesis

ABSTRACT

A prosthetic limb and process to digitally construct a prosthetic limb which includes first, digitally producing a modified mold of a residual limb via 3d scanners and software; constructing a test socket from the digitally modified mold and be equipped with an alignable system; accurately scanning the test socket, along with finalized alignment that has been recorded and adjusted by a certified practitioner to provide a 3-D Image of the finalized prosthetic alignment; transferring the finalized digital alignment of the test socket to the finalized digitally modified mold; once the modified model has received the transferred alignment, fabricating the type of hookup in the socket; i.e., plug fit, four hole, support drop lock, or any other type of industry standard connection or accommodation via basic 3D software; and once the desired prosthetic attachment is finalized, sending finished file to a 3-D printer to produce the definitive prosthetic device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a nonprovisional patent application of U.S. Provisional PatentApplication Ser. No. 61/674,720, filed Jul. 23, 2012, which is herebyincorporated herein by reference.

Priority of U.S. Provisional Patent Application Ser. No. 61/674,720,filed Jul. 23, 2012, incorporated herein by reference, is herebyclaimed.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable

REFERENCE TO A “MICROFICHE APPENDIX”

Not applicable

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to prosthetics. More particularly, thepresent invention relates to a novel process for constructing aprosthetic limb through a series of fabrication steps includingretrieving a file from a computer, manipulating that file that hascaptured alignment and socket fit, sending it to a 3D printer, which inturn has the ability to print out a completed, wearable prosthetic limbof strong plastic material, such as ULTEM® (A Registered Trademark ofGeneral Electric Co.), carbon fiber, or other material of equivalent orgreater strength that may be known or developed in the future.

2. General Background of the Invention

The design of an effective prosthetic socket is crucial to therehabilitation and overall health of a person with an amputated limb.Most of the time and energy a practitioner applies in making aprosthesis is spent on fabricating the socket that must be fitted to theresidual limb. The prosthetic socket must be shaped so that it supportsthe residual limb in load tolerant areas, while avoiding irritation ofsensitive regions on the limb that contact the inner surface of thesocket. If these criteria are not achieved, when the patient uses theprosthesis, residual limb soft tissue breakdown often occurs. The resultis painful sores, blisters, ulcers, or cysts on the residual limb thattypically restrict continued prosthesis use, and in severe cases,necessitate a further amputation to a higher anatomical level, which canlead to further disability. The incidence of skin breakdown inlower-limb amputees has been reported to be from 24% to 41%.Accordingly, at any one time, as many as 41% of prosthesis users may beexperiencing breakdown of the tissue on the residual limb. The principalcause of such breakdown is a poorly fitting prosthetic socket.

Practitioners face challenges in making quality sockets for theincreasing amputee popularity. Also, there is a shortage of prosthetistsin the industry, and that shortage is expected to increase in thefuture, as the demand for prosthetic devices increases. A prosthetist'stime is precious and must be used as efficiently as possible. It willtherefore be evident that there is a need for technology to improve aprosthetist's efficiency, speed, documentation, repeatability, andquality of fitting a socket to a patient's residual limb, and to ensurea proper socket design early in the process of fitting a prostheticsocket to a recipient.

In the current state of the art, one way of capturing an image of aresidual limb in order to gather a positive mold is by hand casting. Theprocedure one would use in the traditional format of hand casting wouldfollow certain steps. The initial step would include the followingmaterials and tools needed for measuring the patient: stockinette,plaster bandages, indelible pencil, preparations for suspension(example: silicone liners, foam liners, hard socket), also measuringtools such as a length stick M/L gauge and tape measure. These tools andmaterials would assist a prosthetist in taking the proper cast alongwith techniques they acquired through training.

After the proper cast has been taken by a certified individual, thefabrication of the test socket would be as follows. First, one wouldpour the negative mold or cast in order to receive the positive moldwith a powder substance called plaster of paris. Once the plasterhardens, the next step is striping the plaster bandages off of the mold.Then the positive mold is modified by hand to achieve its voids andpressure points in precise locations with plaster of paris. After thedesired reliefs are added it is then ready for a term used in theindustry known as either drap pull or bubble pull. These are techniquesin which a clear plastic is pulled over the positive model. Therefore,this manual technique for capturing an image of a residual limb in orderto gather a positive mold is greatly improved upon by the use of adigital process as will be described herein.

The following U.S. patents are incorporated herein by reference:

Patent No. Title Issue Date 7,447,558 Apparatus for Determining A ThreeNov. 4, 2008 Dimensional Shape of an Object 7,225,050 Method andApparatus for Precisely May 29, 2007 Fitting, Reproducing, and Creating3-Dimensional Objects from Digitized and/or Parametric Data Inputs UsingComputer Aided Design and Manufacturing Technology 7,162,322 CustomProsthetic Liner Manufacturing Jan. 9, 2007 System and Method 6,463,351Method for Producing Custom Fitted Oct. 8, 2002 Medical Devices2010/0161076 Orthotic or Prosthetic Cushioned Device Jun. 24, 2010 andMethod of Making the Same 2010/0023149 Computer Aided Design and Jan.28, 2010 Manufacturing of Transtibial Prosthetic Sockets 2006/0020348Method and Associated System for Jan. 26, 2006 Recording and RetrievingFabrication and/or Fitting Data Associated with a Prosthetic Component2006/0094951 Computer-Aided-Design of Skeletal May 4, 2006 Implants

BRIEF SUMMARY OF THE INVENTION

The method and process of the present invention solves the problemsconfronted in the art in a simple and straightforward manner. What isprovided is a process for making a prosthetic limb, wherein one wouldretrieve a manipulated file from a computer that has been through thetest socket phase; that file will be manipulated through the definitivesocket phase using specific 3D prosthetic software to design the socketfor current practiced methods. Thereafter it will be ready to be sent toa 3D printer, which in turn has the ability to print out the prostheticlimb from a material, such as a strong plastic material, ULTEM®, orcarbon fiber, or other material of equivalent or greater strength thatmay be known or developed in the future.

More specifically, the steps in this inventive process include, first,digitally producing a modified mold of a residual limb via 3D scannersand software known to the industry. A test socket would be constructedfrom the digitally modified mold and be equipped with an alignablesystem; for example, a pylon, along with the desired prosthetic foot.The test socket would be accurately scanned, preferably with a 3Dscanner, along with finalized alignment that has been recorded andadjusted by a certified practitioner to provide a 3-D Image of thefinalized prosthetic alignment. The next step would be to transfer thefinalized digital alignment of the test socket to the finalizeddigitally modified mold. Once the modified model has received thetransferred alignment, one would proceed to fabricate the type of hookupin the socket; i.e., plug fit, four hole, support drop lock, or anyother type of industry standard connection or accommodation via basic 3Dsoftware. Once the desired prosthetic attachment is finalized, the nextstep is to send the finished file to a 3-D printer to produce thedefinitive prosthetic device. One such printer is sold under thetrademark of Fortus® which would be utilized in this process designed byStratasys, but there may be other such printers available. Preferably,the prosthesis would be printed out of a material such as ULTEM®, orcarbon fiber, or other material of equivalent or greater strength thatmay be known or developed in the future.

As stated earlier, by utilizing this process, the prosthetist is allowedto construct the prosthesis with prosthetic techniques for attachmentssuch as:

-   -   Four hole hook up with vacuum    -   Four hole hook up that will support a drop lock    -   Fitting of pylon or adapters    -   Custom attachments (for certain feet/attachment)

Therefore, it is a principal object of the present invention to providea prosthesis and a method to fabricate a prosthesis constructed of aplastic material such as ULTEM®, or carbon fiber, or other material ofequivalent or greater strength that may be known or developed in thefuture, through the use of digital manipulation of a file that hascaptured the alignment and the socket measurements, then created adefinitive prosthesis by a method which can be done in an efficient rateand manner than the conventional methods which are time consuming.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

For a further understanding of the nature, objects, and advantages ofthe present invention, reference should be had to the following detaileddescription, read in conjunction with the following drawings, whereinlike reference numerals denote like elements and wherein:

FIG. 1 illustrates a modified mold of a residual limb digitally producedvia 3D scanners and software:

FIG. 2 illustrates a carving of the modified model before it goes withthe test socket to be fabricated;

FIGS. 3A and 3B illustrate two views of a fabricated test socket whichis hooked up to an alignment or an alignable system respectively;

FIGS. 4A through 4B illustrate steps in the scanning of the test socketand the alignment, with FIG. 4C illustrating the captured alignment;

FIGS. 5A and 5B illustrate the modified mold and the beginning stages oftransferring alignment, illustrating the addition of the pylon;

FIG. 6 illustrates the process of cross-referencing of the modified moldwith the alignment attachment with the test socket with the correctalignment;

FIG. 7 is the completed merge of the process illustrated in FIG. 6 toassure the correct alignment;

FIG. 8 is an image of the socket after alignment has been captured andwith the use of CAD software showing a four hole hookup adapted to thesocket;

FIG. 9 is an actual printout of the image in FIG. 8 showing the fourhole hookup;

FIG. 10 is a printout of the prosthesis which has a plug fit adaptor;

FIG. 11 is a printout of the prosthesis which has a plug fit where apylon or adaptor can be engaged; and

FIG. 12 is a Flow Chart illustrating a preferred embodiment of themethod or process of constructing a prosthetic limb through a digitalformat.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 through 12 illustrate a preferred embodiment of the method orprocess of constructing a prosthetic limb through a digital format.

Before reference is made to the Figures, in general, this technique ofachieving a positive mold for a test socket in a digital format is byscanning the residual limb. The first step would be to choose thematerials and tools needed for measuring a patient. Again, one wouldneed to prepare suspension of the prosthesis (silicone liner, foam orother types of socket designs); a scanner; a laptop; reflective dots;measuring tools such as a length stick M/L gauge tape measure, etc. Themethod may vary by which Distal Device used.

After preparing oneself with the items one would need to take a digitalimage of a residual limb, the individual would use a scanner to capturethe digital image of the limb. After the limb is captured, theindividual would use a prosthetic software which is already known in theart, to modify the 3-D image or positive mold to achieve its relief andpressure points in precise locations. In essence one would modify theresidual limb with the same basic techniques that are taught and used inthe pre-scanner era or plastic molds.

After modifying the mold in the desired manner via CAD, the positivemold is designed, and the final stages of a test socket is near. Beforeone would vacuum pull a test socket, a trained individual woulddetermine the proper plastic material, and certain mechanicalattachments were needed. Also required is the technique discussedearlier of forming the plastic over the mold (drape or bubble pull).Finally, after the plastic has cooled to a workable form, one wouldclean the proper trim lines, make final mechanical preparations andfinalize the test socket before fitting the patient.

During the fitting of the test socket, one would observe pressure pointsand proper fit of the test socket. Next, one would make adjustments ifneeded and fabricate a second socket if need be. At this time, alignmentcan be observed and obtained.

When the fabrication of the definitive sockets materials have cured, thesocket is removed from the mold and trimmed out. It is then applied tothe desired prosthetic components in the final delivery, i.e., duringthe fit/walk, the prosthetist is looking for the proper fit of socketand the correct alignment that correspond to the patient's gait.

In the process of the present invention, the individual would receivethe aligned test socket, then one would capture the alignment andachieve a digital alignment via scanners and CAD systems along with thefinal test socket, the images can be merged to create a positive mold inan alignment.

Once the digital prosthetic design is complete and approved, it is thensent to a 3-D printer where it is then printed or fabricated as awearable prosthetic limb. As stated earlier, one such printer is soldunder the trademark of Fortus® which would be utilized in this processdesigned by Stratasys, although there may be other such printersavailable for use.

During this process the preferred material may be a plastic, such asULTEM®, or carbon fiber, or other material of equivalent or greaterstrength that may be known or developed in the future, while theprinters are a product of Stratasys Corporation or other such types ofprinters. After the print is complete, the prosthetic limb is thenshipped to the prosthetist. Upon delivery, the prosthetist will have analigned prosthesis and would have the ability to finish the proper trimlines. During fit/walk the prosthetist is looking for the proper fit ofsocket and the correct alignment that corresponds to the patient's gait.

Turning now to FIGS. 1 through 11, there is illustrated the varioussteps involved in the method of the present invention. In FIG. 1 thereis illustrated a modified mold 10 of a residual limb which has beendigitally produced via 3D scanners and software known in the industry.As illustrated, the modified mold 10 would include the relief andpressure points 11 of a test socket which would be actually molded. InFIG. 2, there is illustrated a carving 13 of a modified model before itis matched with the test socket to be fabricated. Turning to FIG. 3Athere is illustrated an actual test socket 12 which has been constructedfrom the digitally modified mold 10, which is hooked up to an alignmentsystem 15, having a pylon 16 and a prosthetic foot 17. In FIG. 3B, thetest socket 12 has been equipped with an alignable system 21, includinga pylon 16, together with base 23 of the alignable system 21, ratherthan the prosthetic foot 17 as seen in FIG. 3A. It should be noted thatthe actual test socket 12, as seen in FIGS. 3A and 3B, has also beenequipped with a plurality of dots 20 so as to allow the socket 12 to beaccurately scanned, as covered by the next step in the process.

FIGS. 4A and 4B illustrate the images which appear of the test socket 12as the test socket 12 is being accurately scanned. preferably with a 3Dscanner, along with finalized alignment that has been recorded andadjusted by a certified practitioner to provide a 3-D Image of thefinalized captured prosthetic alignment, or the completed image of thealigned prosthetic limb 22 which is illustrated in FIG. 4C.

In FIGS. 5A and 5B there is illustrated examples of the modified moldand the beginning stages of transferring the alignment. It should benoted that in FIG. 5A, there has been placed a 30 mm adaption (pylon16), while in FIG. 5B there is a shorter adaption (pylon 16) adapted tothe modified mold. The next step would be to transfer the finalizeddigital alignment of the test socket 12 to the finalized digitallymodified mold 10, as is illustrated in FIG. 6. In FIG. 6, the image onthe left is the modified mold 10 with the alignment attachment that canbe manipulated, on the right is the test socket 12 with the correctalignment. In this step, one is merging the alignment of a test socket(inner portion 24 of a prosthesis) with the final manipulated model(outer fit 26 of the prosthesis) as one. This is done by usingtechniques in the software that allows one to overlap the images tocross reference the objects at hand. But first using a certaincylindrical tool in the software to simulate the appearance of a pylon16 (normally 30 mm) needs to be added to the distal portion of the finalmanipulated model (inner model). This will give the individual theoption of lining up the alignment or changing it at this time. Whencross-referenced, both models should line up exactly using the alignmentmodel as reference. In FIG. 7, there is illustrated the final mergedimage 27 of both to assure there is correct alignment which does nothave to be modified or corrected. In the process described above, it isforeseen that in the future this process as described herein will beaccomplished through software to be developed.

In FIG. 8, after the alignment has been captured, as described above,the next step is to use CAD software to proceed to fabricate the type ofhookup in the definitive socket 28; i.e., plug fit, four hole (the typeillustrated in FIG. 8), support drop lock, or any other type of industrystandard connection or accommodation via basic 3D software. In FIG. 9,there is illustrated the actual printout of the prosthesis, alsoreferred to as definitive socket 28, that was illustrated in FIG. 8,showing the four hole hookup 30 mounted on the definitive prostheticsocket 28. One such printer is sold under the trademark of Fortus® whichwould be utilized in this process designed by Stratasys, although othersuch printers are available. Preferably, the definitive socket 28prosthesis would be printed out of a plastic material such as ULTEM®, orcarbon fiber, or other material of equivalent or greater strength thatmay be known or developed in the future.

In addition to the four hole hookup 30 as illustrated in FIG. 9, FIG. 10illustrates a printout of the prosthesis 28 which has a plug fit adaptor32, while in FIG. 11 the prosthesis 28 is adapted with a plug fit 34 forreceiving a pylon 16 or other type of adaptor.

As stated earlier, by utilizing this process, the prosthetist is allowedto construct the prosthesis with prosthetic techniques for attachmentssuch as:

-   -   Four hole hook up with vacuum    -   Four hole hook up that will support a drop lock    -   Fitting of pylon or adapters    -   Custom attachments (for certain feet/attachment)

In the preferred method of the present invention it is foreseen that thesocket will undergo sealing. In order to seal the socket the step willinclude adding a layer of epoxy to the exterior of the socket, whichwould help to add strength to the entire socket. The preferred type ofepoxy is described as TC-1614 A/B epoxy, manufactured by BJBEnterprises, or an equivalent type, which will be laminated over thesocket. This will seal the socket in order to be able to use vacuum forproper fitting, if required.

In addition to the Drawing Figures as discussed above, reference is madeto FIG. 12, a Flow Chart which succinctly depicts the steps in theprocess of the present invention making reference to the appropriateddrawing Figures as discussed herein.

All measurements disclosed herein are at standard temperature andpressure, at sea level on Earth, unless indicated otherwise. Allmaterials used or intended to be used in a human being arebiocompatible, unless indicated otherwise.

PARTS LIST Modified mold 10 Pressure points 11 Test socket 12 Carving 13Alignment system 15 Pylon 16 Prosthetic foot 17 Dots 20 Alignable system21 Aligned prosthetic limb 22 Base 23 Inner portion 24 Outer fit 26Merged image 27 Definitive socket 28 Four hole hookup 30 Plug FitAdaptor 32 Plug fit 34

The foregoing embodiments are presented by way of example only; thescope of the present invention is to be limited only by the followingclaims.

The invention claimed is:
 1. A process to digitally construct aprosthetic limb, comprising the following steps: a) digitally producinga modified mold of a residual limb via 3D scanners and software; b)constructing a test socket from the digitally modified mold of theresidual limb; c) equipping the test socket with an alignable system,including a pylon, along with a base member; d) aligning the test socketequipped with the alignable system and determining a finalizedprosthetic alignment of the test socket; e) scanning the test socket inthe finalized prosthetic alignment to provide an image of the finalizedprosthetic alignment; and f) transferring the finalized prostheticalignment of the test socket to a finalized digitally modified mold ofan aligned socket.
 2. The process in claim 1, wherein the test socket inthe finalized prosthetic alignment is scanned with a 3D scanner.
 3. Theprocess in claim 1, further comprising after step “f” fabricating ahookup in the finalized digitally modified mold of the aligned socket,the hookup for a prosthetic attachment, via software.
 4. The process inclaim 3, further comprising creating a finished file once the hookup forthe prosthetic attachment is fabricated and sending the finished file toa printer to produce the aligned socket with the hookup.
 5. The processin claim 4, wherein the printer is a 3-D Fortus® printer.
 6. The processin claim 2, wherein the prosthetic limb is printed out of a plasticmaterial.
 7. The process in claim 1, further comprising fabricating anattachment in the finalized digitally modified mold of the alignedsocket, via software, the attachment selected from a group comprising:a) a four hole hook up with vacuum; b) a four hole hook up that willsupport a drop lock; c) a fitting of cylindrical adapter; and d) acustom attachment for receiving a foot or other attachment member. 8.The process in claim 1 wherein the base member is a prosthetic foot. 9.The process in claim 2 wherein the prosthetic limb is printed out ofcarbon fiber.
 10. The process in claim 3 wherein the hookup is a plugfit, a four hole fit, or a support drop lock.
 11. The process in claim 4wherein the prosthetic limb is in alignment and wearable by a patientafter being printed.
 12. The process in claim 6 wherein the material isULTEM® plastic.
 13. The process in claim 1 wherein in step “f” thefinalized prosthetic alignment is for an inner portion of the prostheticlimb, and the finalized digitally modified mold is for an outer portionof the prosthetic limb, and wherein when transferring the finalizedprosthetic alignment of the test socket to the finalized digitallymodified mold the finalized prosthetic alignment of the test socket ismerged with the finalized digitally modified mold.
 14. A digitallyfabricated prosthetic limb, wherein a finished limb is aligned andcapable of being worn by a patient, the digitally fabricated prostheticlimb fabricated under the following process: a) digitally producing amodified mold of a residual limb via 3d scanners and software; b)constructing a test socket from the digitally modified mold; c)equipping the test socket with an alignable system, including a pylon,along with a prosthetic foot; d) aligning the test socket with thealignable system and recording a finalized prosthetic alignment; e)accurately scanning the test socket, along with the finalized prostheticalignment, to provide a 3-D image of the finalized prosthetic alignment;and f) using software to transfer the finalized prosthetic alignment ofthe test socket to a finalized digitally modified mold of an alignedsocket.